BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 7586224 · Received June 11, 2018

    Report

    Report Number
    2648988-2018-00024
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    December 2, 2017
    Report Date
    May 21, 2018
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 1170959 WAS REVIEWED AND NO ANOMALY WAS OBSERVED THAT COULD HAVE CAUSED THE REPORTED CONDITION. ALSO, NO EVENT WAS RECORDED FOR THE MENTIONED LOTS; THUS, THE LOTS COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. DOCUMENT REVIEW DOES NOT SHOW ANY EVENT THAT COULD CAUSE THE REFERRED BREAKAGE. SINCE NO SAMPLE WAS RETURNED THE COMPLAINT COULD NOT BE CONFIRMED; DOCUMENTATION REVIEW SHOWS THAT THERE ARE CONTROLS TO PREVENT THIS TYPE OF DEFECT AT THE MANUFACTURING SITE; NO FURTHER EVALUATION IS POSSIBLE AT THIS MOMENT.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBER 2648988-2018-00026.

    Description of Event or Problem · 1

    (B)(6) VOLUNTARY EVENT REPORT (FOI FOR MANUFACTURERS) MW5076829 WAS RECEIVED ON (B)(6) 2018. ON (B)(6) 2017, AN INS8401 ACCUDRAIN WITH ANTI-REFLUX HAD A CRACK TO THE PROXIMAL PORT AND WAS BROKEN AT THE STOPCOCK. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429943 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1170959

    Patients

    Seq Age Sex Outcome Treatment
    1